12:00 AM
Nov 12, 2007
 |  BioCentury  |  Finance

Ebb & Flow

Onyx (ONXX) soundly beat the 3Q07 consensus EPS estimate of a $0.21 loss per share last week, turning a bit of a profit at $0.01 a share. The surprise came because analysts hadn't accounted for the strength of off-label Nexavar sorafenib sales to treat liver cancer.

For the quarter, Nexavar net revenue was $105 million. That was up 130% from $45 million in 3Q06 and 29% from $81 million in 2Q07. ONXX chalked up the growth to off-label liver cancer sales, noting that kidney cancer sales are "essentially stable."

Nexavar is partnered with Bayer (FSE:BAY) and all revenue is recorded by the pharma. Thus buysider Sven Borho of OrbiMed said he expects ONXX will be bought by its partner. "This is Bayer's key pipeline product and they will have to buy the company before any possible data in lung cancer," he concluded.

Nexavar is in a Phase III trial to treat advanced non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel. Data are anticipated in 2H08.

Earlier this month, the EC approved a label expansion for Nexavar to include hepatocellular carcinoma (HCC). ONXX and BAY hope to have reimbursement in HCC finalized with Germany, France, Italy and Spain by the end of 1Q08. The companies expect an FDA decision on an sNDA for Nexavar to treat HCC by year end. ONXX and BAY have also filed for approval to treat HCC in some Asian countries, including Japan and China.

ONXX presented positive Phase III data in HCC at the American Society of Clinical Oncology (ASCO) meeting in early June, which the company said was the primary driver of its 3Q sales growth (see BioCentury, June 11).

In October, Nexavar was also included in the National Comprehensive Cancer Network's guidelines for the treatment of liver cancer. It's now listed as a treatment option for metastatic or unresectable disease and for those who decline surgery.

The company expects use in HCC to continue to drive growth. "With no other systemic therapy approved for liver cancer, we believe Nexavar is poised to become the new standard of care for this disease," noted Chairman, President and CEO Hollings Renton, who will be retiring as president and CEO next year while remaining as chairman.

Still, ONXX isn't committing to maintaining profitability quite yet. Renton cautioned that 4Q expenses related to ongoing trials and the launch of Nexavar in HCC could be an issue. He also noted that, historically, expenses have tended to be higher for ONXX in the fourth quarter. Renton said he would address the issue of profitability again on the 4Q call in February.

The stock finished the week up $7.16 (15%) to $56.50.

Ablynx hot . . .

Belgian Nanobody company Ablynx may have only one compound in Phase I, but it proved to be as hot as other second generation protein and antibody companies are these days. But whereas other companies are being snapped up by acquirers, Ablynx did the biggest-ever biotech IPO on Euronext Brussels.

Ablynx (Euronext:ABLX) raised E75 million ($108.9 million), selling 10.7 million shares at E7, valuing the company at E243.3 million ($353.1 million) (see "Brussel's IPOs").

Boehringer Ingelheim invested E15 million ($21.8 million) in the offering in connection with a September deal to develop proteins using Nanobodies, which are therapeutic proteins based on single-domain antibody fragments (see BioCentury, Sept. 10).

Retail investors were allocated 1.2 million shares, or 10% of the offering.

Investor GIMV held a 14.21% pre-IPO stake, while Biotech Fonds Vlaanderen, which is managed by GIMV, held an additional 9.8%. Their combined 24.01% stake made GIMV the largest shareholder. Other investors include VIB (Flemish Institute of Biotechnology); Sofinnova Ventures; Gilde; Abingworth Bioventures; and Boehringer Ingelheim.

ABLX's lead compound is ALX-0081, a Nanobody targeting von Willebrand Factor (vWF) that is expected to start a Phase II trial next year to reduce the risk of thrombosis in patients with acute coronary syndrome (ACS).

Although the IPO priced toward the lower end of its proposed range of E6.50-E8.50, ABLX gained E0.24 to E7.24 in its first week of trading.

JPMorgan and KBC...

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